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Cyclin D1 Based TPF Induction Chemotherapy for Oral Squamous Cell Carcinoma Patients at Clinical N2 Stage

ConditionsMouth NeoplasmsCarcinoma, Squamous Cell
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Jiao Tong University School of Medicine

About this trial

The purpose of this study is to To confirm the predictive value of CCND1 for TPF induction in cN2 patients with OSCC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 to 75 years old.

Sex: both males and females.

Karnofsky performance status (KPS) >60.

Histological biopsy confirming squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region).

Disqualifiers

Evidence of distant metastatic disease and other cancers.

Surgical procedure of the primary tumors or lymph nodes (except diagnostic biopsy).

Previous radiotherapy or chemotherapy.

Other previous malignancies within 5 years.

Trial design

Design model

Parallel

Treatments tested in this trial

  • TPF group

    Drug

    The patients in the experimental group received the TPF induction chemotherapy for 2 cycles followed by radical surgery and post-operative radiotherapy. docetaxel:75mg/m2 cisplatin：75 mg/m2 5-Fu：750 mg/m2/day

  • surgery group

    Procedure/Surgery

    The patients in the control group received the radical surgery and post-operative radiotherapy.

  • Post-operative radiotherapy

    Radiation

    Radiotherapy was arranged 4 to 6 weeks after surgery. Routine external beam radiotherapy, such as conformal or intensity modulated radiotherapy was performed, and the dose was 1.8-2 Gy/day, 5 days/week for 6 weeks, and totally 54-60 Gy.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: TPF groupExperimental treatment 3 interventions
Group B: surgery groupOther 2 interventions

Trial outcomes

Primary outcomes

1

overall survival rate as a measure by the numbers of living patients

Time frame
2 year

Secondary outcomes

1

disease free survival as a measure by the number of patients without recurrence or death

Time frame
2 year
2

local recurrence free survival as a measure by the number of patients without recurrence

Time frame
2 year
3

distant metastasis free survival as a measure by the number of patients without metastasis

Time frame
2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jiao Tong University School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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